Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2026-02-28

Brief Summary

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This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts:

* Long Covid (LC)
* Post-treatment Lyme disease syndrome (PTLDS)
* Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

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Detailed Description

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Conditions

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Long Covid Post-treatment Lyme Disease Syndrome Chronic Fatigue Syndrome Myalgic Encephalomyelitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Long Covid

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Group Type EXPERIMENTAL

Lumbrokinase

Intervention Type DIETARY_SUPPLEMENT

Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.

Post-treatment Lyme Disease Syndrome

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Group Type EXPERIMENTAL

Lumbrokinase

Intervention Type DIETARY_SUPPLEMENT

Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Group Type EXPERIMENTAL

Lumbrokinase

Intervention Type DIETARY_SUPPLEMENT

Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.

Interventions

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Lumbrokinase

Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Boluoke® Lumbrokinase

Eligibility Criteria

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Inclusion Criteria

* Any gender
* Aged 18+
* Baseline EQ-VAS ≤70; EQ-VAS before the index infection ≥80 (this information is collected as part of the baseline survey).
* Diagnosed with only one of the following conditions:
* Long Covid
* Documented clinical history of confirmed or suspected acute COVID-19 infection a minimum of 3 months prior to contact with the study team
* Formal diagnosis of Long Covid from a physician
* Post-treatment Lyme disease syndrome
* Diagnosis will be based on participants meeting either Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria:

* Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition Erythema Migrans History of possible exposure to a high incidence county or state (or an adjacent area) Erythema migrans rash

* EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine)
* EM 1A: MOA self-report \& medical record documentation of rash \> 5 cm
* EM 1B: MOA: self-report and medical record documentation of EM rash but not size
* EM 1C: MOA: self-report \& rash misdiagnosed in medical record as cellulitis/spider bite
* EM 1D: MOA: self-report and either: photo of EM or Class 1 lab test confirmation within 4 weeks of illness onset OR
* Disseminated "objective" manifestation with lab test confirmation of Bb infection
* Clinical history includes at least one of the following symptoms/signs, which are not better accounted for by another cause (MOA: medical records and/or self-report).
* Neurologic: Lymphocytic Meningitis ; Encephalitis; Encephalomyelitis Cranial Neuritis (especially facial palsy); Radiculoneuropathy; Other Neurologic Signs (with objective measures) : Encephalopathy, Polyneuropathy
* Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis
* Lyme arthritis: Recurrent joint swelling in one or more joints
* Dermatologic: Disseminated EM ("satellite") or Acrodermatitis atrophicans AND
* Lab test Confirmation (requires at least one of the Class 1 lab tests) (MOA: self-report \& documentation)
* Group 2. Probable

* 2A. Chronic Multisystem Symptoms attributed to Lyme disease (insufficient to meet Group 1) and not better explained by another diagnosis and patient has evidence of positive lab results on a Class 1 lab test (or 4 of 10 bands for IgG Western blot (WB)) (MOA: self-report with lab documentation Class 1 lab test confirmation (excluding IgM WB) Highly suggestive IgG WB (4 of 10 bands) OR
* 2B. EM rash by history after exposure to a Lyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 lab test confirmation is available (MOA: self-report) OR
* 2C. Viral like illness (not better explained by other cause) with indeterminate or + enzyme immunoassay (EIA) with positive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report) OR
* 2D. Viral like illness (not better explained by other cause) with indeterminate or positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM)
* (MOA: medical records, lab test and self-report)
* (MOA: lab test and self-report)
* ME/CFS
* Formal diagnosis of ME/CFS prior to 2020 from a physician
* Actively symptomatic such that the 2011 International Criteria for ME/CFS is met at time of screening

Exclusion Criteria

* Current use of antiplatelet or anticoagulation regimen
* Diagnosis of an autoimmune condition such as Chronic EBV, Multiple Sclerosis, Hashimoto's Disease, etc. which would impact the immunological profiling analysis.
* Pregnancy or lactation
* Known allergy to earthworms (Lumbrokinase is a supplement that is derived from earthworms)
* Past medical history of a bleeding or clotting disorder
* Has a scheduled surgery during, or immediately after, the study period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No